Dietary supplements and methods for treating pain and inflammation

ABSTRACT

The invention provides compositions such as dietary supplements. Such compositions can be used to reduce pain, inflammation, stiffness, and/or discomfort associated with inflammatory conditions such as arthritis. The invention also provides methods for reducing pain, inflammation, stiffness, and/or discomfort associated with inflammatory conditions such as arthritis.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional (and claims the benefit of priorityunder 35 USC 120) of U.S. application Ser. No. 10/039,246, filed Jan. 4,2002 now U.S. Pat. No. 6,713,096. The disclosure of the priorapplication is considered part of (and is incorporated by reference in)the disclosure of this application.

BACKGROUND

1. Technical Field

The invention relates to dietary supplements as well as methods forreducing pain, inflammation, and stiffness associated with inflammatoryconditions such as arthritis.

2. Background Information

Inflammatory conditions such as arthritis and osteoarthritis are seriousmedical problems that affect many Americans. In fact, arthritis is oneof the nation's most prevalent chronic health problems. An estimated 43million Americans suffer from some form of arthritis. According to theArthritis Foundation, this figure is expected to jump to about 60million within the next decade.

Osteoarthritis (OA), also known as degenerative joint disease, is themost common form of arthritis. By age 40, about 90 percent of all peoplehave x-ray evidence of OA in the weight bearing joints such as the hipsand knees. In addition, more than 20 million American currently havesymptoms of OA. Severe involvement of the hips, knees, and spinal columncan greatly limit activity and diminish the overall quality of life. Thegradual breakdown of cartilage that accompanies aging is the leadingcause of OA. This type of OA, called primary osteoarthritis, is causedby cartilage damage resulting mostly from stress on the joint from, forexample, obesity. The first alteration in the joint, which takes placeover decades, is a roughening of articular cartilage followed bypitting, ulceration, and progressive loss of cartilage surface. PrimaryOA most commonly involves the joints of the fingers, hips, knees, spine,base of the thumb, and big toe. It can be present in just one of thesejoints or in all of them.

Secondary OA, however, can affect any joint. Typically, secondary OAfollows trauma or chronic joint injury due to some other type ofarthritis such as rheumatoid arthritis. Alternatively, secondary OA canresult from overuse of a particular joint. Although most body tissuescan make repairs following an injury, cartilage repair is hampered by alimited blood supply and the lack of an effective mechanism forcartilage re-growth. The effects of joint overuse were shown in a studythat revealed that subjects whose jobs required at least one hour a dayof kneeling or squatting were almost twice as likely to have OA in theknees than those not commonly performing such activities. Because traumaor overuse hastens the degeneration of cartilage, symptoms of secondaryOA can become apparent at a much younger age than symptoms of primaryOA.

OA symptoms are usually mild at first. For example, morning stiffnessthat rarely lasts for more than 15 minutes is a common early symptom ofOA. As the disease advances, mild pain will occur when moving theaffected joint. The pain typically is made worse by greater activityand-is relieved by rest. In many people, symptoms progress no further.In others, however, the pain and stiffness gradually worsen until theylimit daily activities such as walking, going up stairs, or typing.Enlargement of the finger joints is common in the later stages of OA.Knobby overgrowths of the joints nearest the fingertips occur most oftenin women and tend to run in families.

There are number of treatments that can relive the pain, inflammation,and discomfort associated with OA. One treatment involves the use ofnon-steroidal anti-inflammatory drugs (NSAIDs). Although NSAIDs relievesome stiffness, inflammation, and pain associated with OA, NASIDs canlead to side effects such as gastric bleeding, liver damage, and kidneydamage. In addition, long-term use of NSAIDs can lead to reducedeffectiveness.

SUMMARY

The invention provides compositions (e.g., dietary supplements) forreducing pain, inflammation, and/or stiffness associated withinflammatory conditions such as arthritis or OA. Reducing pain,inflammation, or stiffness associated with an inflammatory condition canhelp improve joint mobility. Typically, such compositions can contain anaminosaccharide, a ginger component, and an enzyme. In addition, thecompositions provided herein can contain other ingredients such as agreen tea extract. The compositions provided herein can be used to helppeople live healthier, more active lives by reducing joint pain,inflammation, or stiffness and/or by rebuilding cartilage. Thecompositions of the invention also provide people suffering from jointproblems with a treatment that can produce detectable benefits within ashort time period (e.g., within a few days of the first administration).In addition, the compositions of the invention can provide peoplesuffering from joint problems with a safe treatment containing naturalingredients. The invention also provides methods for reducing pain,inflammation, and/or stiffness associated with inflammatory conditionssuch as arthritis.

In one aspect, the invention provides a dietary supplement comprising anaminosaccharide, a ginger component, and an enzyme. An aminosaccharidecan be an aminosaccharide salt. Representative aminosaccharides includeglucosamine, glucosamine hydrochloride, glucosamine sulfate, glucosaminephosphate, glucosamine lactate, or glucosamine dodecanoate. Typically,300 mg to 3000 mg (e.g., 1000 mg to 2000 mg) of the dietary supplementis the aminosaccharide. A ginger component can include ginger oil,gingerroot or gingerroot extract. Typically, 50 mg to 10 g (e.g., 100 mgto 500 mg) of the dietary supplement is the ginger component.

Representative enzymes that can be included in a dietary supplement ofthe invention are bromelain, papain, fungal proteases, acid stableproteases, neutral stable proteases, and alkaline stable proteases. Adietary supplement of the invention can include a single enzyme or atleast two different enzymes. Typically, 50 mg to 10 g (e.g., 1000 mg to2000 mg) of the dietary supplement is the enzyme. A dietary supplementof the invention can be in the form of a tablet, a powder, or a liquid.A dietary supplement can include a green tea extract. Typically, 50 mgto 2000 mg (e.g., 100 mg to 1000 mg) of the dietary supplement is thegreen tea extract.

A dietary supplement of the invention can reduce pain, stiffness, orinflammation in a mammal. Generally, administration of the dietarysupplement to a mammal reduces pain, stiffness, or inflammation in themammal within four hours of the administration. In addition, dailyadministration of the dietary supplement to a mammal for at least twoweeks generally reduces pain, stiffness, or inflammation in the mammal.

In another aspect, the invention provides a dietary supplementcomprising: (a) at least about 1500 mg of a glucosamine salt, (b) atleast about 175 mg of a ginger extract, (c) at least about 125 mg of agreen tea extract, and (d) at least about 50 mg of bromelain. In yetanother aspect, the invention provides a tablet comprising: (a) at leastabout 500 mg of glucosamine hydrochloride, (b) at least about 60 mg of aginger extract, (c) at least about 20 mg of a green tea extract, and (d)at least about 20 mg of bromelain.

In still another aspect, the invention provides a method for reducingpain, inflammation, stiffness, or discomfort in a mammal, the methodcomprising administering a dietary supplement, to the mammal, in anamount effective to reduce the pain, inflammation, stiffness, ordiscomfort, wherein the dietary supplement comprises an aminosaccharide,a ginger component, and an enzyme. A representative aminosaccharide isglucosamine. Generally, the mammal receives a daily dose of theglucosamine. A daily dose can be between 2 mg/Kg and 20 mg/Kg of bodyweight of the glucosamine. A representative ginger component is gingeroil. Generally, the mammal receives a daily dose of the ginger oil. Adaily dose can be between 25 mg/Kg and 50 mg/Kg of body weight of theginger oil.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. All publications, patent applications,patents, and other references mentioned herein are incorporated byreference in their entirety. In case of conflict, the presentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

Other features and advantages of the invention will be apparent from thefollowing detailed description, and from the claims.

DETAILED DESCRIPTION

The invention provides methods and materials related to reducing pain,inflammation, and/or stiffness associated with inflammatory conditionssuch as arthritis and OA. Specifically, the invention providescompositions (e.g., dietary supplements) containing an aminosaccharide,a ginger component, and an enzyme. In addition, the compositionsprovided herein can contain other ingredients such as a green teaextract.

Aminosaccharide

A composition of the invention can contain an aminosaccharide. Examplesof aminosaccharides include, without limitation, aminomonosaccharidessuch as glucosamine, galactosamine, allosamine, mannosamime, andfructosamine. Aminomonosaccharides such as glucosamine can be found inglycoprotiens and/or glycoaminoglycans. Glucosamine can be obtained athigh purity from hydrolyses of chitin obtained from shellfish or othercrustacean. Glucosamine has following structure (I) and is typically ina salt form.

where R is an anion such as sulfate, chloride, phosphate, fluoride,bromide, or acetate. In addition, R can be a carboxylate from acarboxylic acid containing C3–C20. Further, R can be an amino acid thathas a net charge of −1 such as glutamic acid or aspartic acid.

Other examples of aminosaccharides include, without limitation, shortchain oligomers or polymers of aminosaccharides such asaminodisaccharides, aminotrisaccharides, aminotetrasaccharides,aminopentasaccharides, and aminooligosaccharides.

Aminosaccharides can be synthesized or derivitized from natural sources.In addition, aminosaccharides can be obtained commercially. For example,glucosamine can be obtained from Technical Sourcing International(Missoula, Mont.), DNP International Co., Inc. (Terre Haute, Ind.),Battlechem Distribution (Westminster, Calif.), Zeta Pharm (Long Beach,Calif.), or Stauber Performance Ingredients Inc. (Fullerton, Calif.).

A composition of the invention can contain one or more than oneaminosaccharide. For example, a dietary supplement can containglucosamine as well as galactosamine. In addition, a composition cancontain any amount of an aminosaccharide. For example, at least 5percent (e.g., at least 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or90 percent) of a dietary supplement can be aminosaccharide. Typically, adietary supplement contains between 50 mg and 5000 mg of anaminosaccharide such as glucosamine. A composition can be formulated tocontain an amount of aminosaccharide such that a daily dose of between300 mg to 3000 mg aminosaccharide (e.g., between 1000 mg to 2000 mgaminosaccharide) can be conveniently administered.

Ginger

A composition of the invention can contain a ginger component. Examplesof ginger components include, without limitation, dried ginger (e.g.,dried gingerroot), ginger oil, and ginger extracts. A ginger componentcan be obtained from any of the estimated 1300 species of plants thatbelong to the Zingiberaccae family. Typically, a ginger component isderived from Zingiber officinale, Alpinia officnarum, or Alpiniagalanga.

Any method can be used to prepare a ginger component. For example,standard harvesting and drying methods can be used to prepare driedgingerroot. Ginger oil can be obtained using standard methods andprocessed with cellulose for making tablet or powder compositions. Aginger extract can be made using an ethanol or hydroalcoholicextraction. Such extracts can be standardized to, for example, 5 to 75percent gingerol or shogaol. In addition, ginger components can beobtained commercially. For example, dried ginger, ginger oil, and gingerextract can be obtained from Buckton Scott Nutrition, Inc. (Fairfield,N.J.), FCC Inc. (NJ), Pure World, Inc (Hackensack, N.J.), or SabinsaCorporation (Piscataway, N.J.).

A composition of the invention can contain one or more than one gingercomponent. For example, a dietary supplement can contain driedgingerroot as well as ginger extract. In addition, a composition cancontain any amount of a ginger component. For example, at least 5percent (e.g., at least 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or90 percent) of a dietary supplement can be a ginger component.Typically, a dietary supplement contains between 5 mg and 50 g of aginger component. A composition can be formulated to contain an amountof a ginger component such that a daily dose of between 50 mg to 1000 mgginger component (e.g., between. 100 mg to 500 mg ginger component) canbe conveniently administered. For example, a composition can beformulated to contain 100 mg of a ginger component. When driedgingerroot is used, the composition can be formulated to contain anamount of dried gingerroot such that a daily dose of between 150 mg to10 g dried gingerroot (e.g., between 1000 mg to 5000 mg driedgingerroot) can be conveniently administered. When ginger oil is used,the composition can be formulated to contain an amount of ginger oilsuch that a daily dose of between 50 mg to 1000 mg ginger oil (e.g.,between 100 mg to 500 mg ginger oil) can be conveniently administered.The ginger oil can be extracted with hydrocarbon solvent or distilled toprovide 1 to 50 percent gingerol and shogaol. When ginger extract isused, the composition can be formulated to contain an amount of gingerextract such that a daily dose of between 100 mg to 2000 mg gingerextract (e.g., between 150 mg to 1000 mg ginger extract) can beconveniently administered.

Enzyme and Enzyme Mixtures

A composition of the invention can contain an enzyme. Examples ofenzymes include, without limitation, bromelain, papain, fungalproteases, acid stable proteases, neutral stable proteases, and alkalinestable proteases. Enzymes useful in the invention can be derived fromany source such as porcine, bovine, fungi, or plants.

Any method can be used to obtain an enzyme. For example, standardprotein isolation techniques can be used to obtain an enzymepreparation. In addition, enzymes such as bromelain and papain can beobtained commercially. For example, enzymes can be obtained fromNational Enzyme Company (Forsyth, Mont.), American Laboratories.Incorporated (Omaha, Nebr.), Botanical International (Long Beach,Calif.), or Marcor Development Corporation (Carlstadt, N.J.).

A composition of the invention can contain one or more than one enzyme.For example, a dietary supplement can contain a single enzyme or anenzyme blend. In addition, a composition can contain any amount ofenzyme. For example, at least 5 percent (e.g., at least 10, 15, 20, 25,30, 35, 40, 50, 60, 70, 80, or 90 percent) of a dietary supplement canbe enzyme. Typically, a dietary supplement contains between 5 mg and 50g of an enzyme. A composition can be formulated to contain an amount ofenzyme such that a daily dose of between 25 mg to 2000 mg enzyme (e.g.,between 50 mg to 1000 mg enzyme) can be conveniently administered. Forexample, a composition can be formulated to contain 50 mg of an enzymeblend.

Green Tea Extract

A composition of the invention can contain a green tea extract. A greentea extract is an extract derived from Camellia sinensis. Any method canbe used to obtain a green tea extract. For example, a green tea extractcan be obtained by drying (e.g., freeze drying or spray drying) a liquorfrom an alcoholic, hydroalcoholic, or other hydrocarbon extraction. Inaddition, a green tea extract can be dried and standardized to containat least about 25 percent total phenols. A green tea extract can containcatechin, epicatechin, gallocatechin, epigallocatechin, epicatechingallate, and epicatchingallate. Typically, a composition provided hereincontains a green tea extract having at least about 15 percent ofcatechin group compounds. A green tea extract can be caffeinated ordecaffeinated. In addition, a green tea extract can be obtainedcommercially. For example, a green tea extract can be obtained fromBuckton Scott Nutrition, Inc. (Fairfield, N.J.), Pure World, Inc.(Hackensack, N.J.), Sabinsa Corporation (Piscatawayt, N.J.), or StauberPerformance Ingredients Inc., (Fullerton, Calif.).

A composition of the invention can contain one or more than one greentea extract. In addition, a composition can contain any amount of agreen tea extract. For example, at least 5 percent (e.g., at least 10,15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or 90 percent) of a dietarysupplement can be a green tea extract. Typically, a dietary supplementcontains between 10 mg and 20 g of a green tea extract. A compositioncan be formulated to contain an amount of a green tea extract such thata daily dose of between 50 mg to 2000 mg of a green tea extract (e.g.,between 100 mg to 1000 mg of a green tea extract) can be convenientlyadministered. For example, a composition can be formulated to contain 50mg of a green tea extract.

Radical Scavengers, Antioxidants, and Reducing Agents

A composition of the invention can contain one or more radicalscavengers, antioxidants, reducing agents, or mixtures thereof.Typically, a dietary supplement contains one or more radical scavengers,antioxidants, reducing agents, or mixtures thereof in an amount thateffectively reduces oxidation or degradation of the ginger component,enzyme component, and/or green tea extract component of the composition.Examples of radical scavengers and antioxidants include, withoutlimitation, ascorbic acid, tocopheryl acetate, tocopheryl palmitate,tocopherol, and butyl hydroxytoluene. Sodium bisulfite is an example ofa reducing agent that can be incorporated into a dietary supplement.

A composition can contain any amount of radical scavengers,antioxidants, reducing agents, or mixtures thereof. For example, atleast 1 percent (e.g., at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20percent) of a dietary supplement can be a radical scavenger,antioxidant, reducing agent, or mixture thereof. Typically, a dietarysupplement contains between 5 mg and 100 g of a radical scavenger,antioxidant, reducing agent, or mixture thereof.

Botanical Extracts

A composition of the invention can contain one or more botanicalextracts (e.g., herbal extracts). Examples of botanical extractsinclude, without limitation, extracts from chamomile, rosemary, aloe,nettle, centella asiatica, ginkgo biloba, bilberry, apple, citrusbioflavonoids, garlic powder, olive oil, and/or blueberry. Such extractscan be dispersible or soluble in aqueous medium.

Any method can be used to obtain a botanical extract. For example, abotanical extract can be obtained from an alcoholic, hydroalcoholic, orother hydrocarbon extraction. In addition, a botanical extract can beobtained commercially. For example, a botanical extract can be obtainedfrom Botanicals International (Long Beach, Calif.).

A composition can contain any amount of a botanical extract. Forexample, at least 1 percent (e.g., at least 2, 3, 4, 5, 6, 7, 8, 9, 10,15, or 20 percent) of a dietary supplement can be a botanical extract.Typically, a dietary supplement contains between 5 mg and 100 g of abotanical extract.

Other Elements

A composition of the invention can contain vitamins and/or minerals.Examples of vitamins and minerals include, without limitation,pyridoxine chloride, gluthione, calcium citrate, magnesium citrate,magnesium oxide, calcium carbonate (e.g., lead-free calcium carbonate),ascorbic acid, zinc acetate, and vitamin B complexes. Vitamins andminerals can help reduce inflammation and rebuild joint cartilage.

In addition, a composition of the invention can contain more than onevitamin. For example, a composition can contain two different vitamins.Likewise, a composition of the invention can contain more than onemineral. For example, a composition can contain two different minerals.

Any method can be used to obtain a vitamin or mineral. For example,vitamins and minerals can be obtained using standard techniques. Inaddition, vitamins and minerals can be obtained commercially.

A composition can contain any amount of vitamins and minerals. Forexample, at least 1 percent (e.g., at least 2, 3, 4, 5, 6, 7, 8, 9, 10,15, or 20 percent) of a dietary supplement can be vitamins and/orminerals. Typically, a dietary supplement contains between 5 mg and 100g of vitamins and/or minerals.

Formulations of a Dietary Supplement

The present invention provides compositions (e.g., dietary supplements)containing a combination of an aminosaccharide, a ginger component, andan enzyme as well as other ingredients such as a green tea extract. Suchcompositions can be used to relieve pain, inflammation, anduncomfortableness due to, for example, OA. In addition, the inventionprovides methods for relieving or reducing pain, inflammation, and/oruncomfortableness due to, for example, OA. Such methods involve theadministration of a composition provided herein.

The compositions provided herein are intended to be ingested (e.g.,orally or intragastrically), but can be administered to a mammal byother routes. For example, a composition provided herein can beadministered nasally, intravenously, intramuscularly, subcutaneously,sublingually, intrathecally, or intradermally. The route ofadministration can depend on a variety of factors, such as theenvironment (e.g., the circumstances resulting in the condition orsymptoms) and therapeutic goals.

When administered orally, the composition can be in the form of a tabletor powder. Tablets and powders can be configured to have a unit dosageequal to the daily desired dosage. For example, if a mammal desires 1000mg of a particular composition, each tablet can be 1000 mg in weight. Asused herein, mammals generally refer to humans, but also can includedomesticated mammals (e.g., dogs, cats, and livestock such as cows,horses, pigs, or sheep) in which reducing pain, inflammation, and/orstiffness is desirable.

The dosages of a particular composition will depend on many factorsincluding the mode of administration. A dietary supplement of theinvention can be formulated in a dose such that an individual receivesabout 1500 mg of glucosamine salt, 50 to 1000 mg of a ginger extract, 50to 2000 mg of a green tea extract, and at least 2 mg/Kg of body weightof enzyme blend in a single tablet.

By way of example, a composition of the invention can be in the form ofa liquid, solution, suspension, tablet, powder, cream, mist, atomizedvapor, aerosol, soft gelatin capsules, or hard gelatin capsules.Commercial dietary supplements are generally formulated for oraladministration. For oral administration, tablets or capsules can beprepared by conventional means with pharmaceutically acceptableexcipients such as binding agents, fillers, lubricants, disintegrants,or wetting agents. The tablets can be coated by methods known in theart. Liquid preparations for oral administration can take the form of,for example, solutions, syrups, or suspension, or they can be presentedas a dry product for constitution with saline or other suitable liquidvehicle before use. Liquid preparations also can containpharmaceutically acceptable additives such as suspending agents,emulsifying agents, non-aqueous vehicles, preservatives, buffer salts,flavoring agents, coloring agents, and sweetening agents as appropriate.Preparations for oral administration can be suitably formulated to givecontrolled release of the compound. Typically, the compositions providedherein are in a powder or tablet form with a fast disintegration time.

In addition, a composition provided herein can contain apharmaceutically acceptable carrier for in vivo administration to amammal. Such pharmaceutically acceptable carriers include, withoutlimitation, sterile aqueous or non-aqueous solutions, suspensions, andemulsions. Examples of non-aqueous solvents include, without limitation,propylene glycol, polyethylene glycol, vegetable oils, and injectableorganic esters. Aqueous carriers include water, alcohol, saline, andbuffered solutions. Pharmaceutically acceptable carriers also caninclude physiologically acceptable aqueous vehicles (e.g., physiologicalsaline) or other known carriers appropriate to specific routes ofadministration. Preservatives, flavorings, and other additives such as,for example, proteins, anti-microbials, chelating agents, inert gases,and the like also can be present in a composition.

The invention will be further described in the following examples, whichdo not limit the-scope of the invention described in the claims.

EXAMPLES Example 1 Dietary Supplements and Tablet Production

Tablet formulation #1 was made using the following ingredients in theamounts indicated:

Ingredient Amount Glucosamine HCl 510.00 mg Calcium Carbonate 269.90 mgGinger Root Extract 60.00 mg Microcrystalline Cellulose 56.00 mgBromelain 25.00 mg Green Tea Extract Powder 20.00 mg Stearic Acid 20.00mg Hydroxy Propyl Cellulose 17.60 mg Croscarmellose Sodium 15.00 mgSilicon Dioxide 6.00 mg Magnesium Stearate 0.50 mg

Tablet formulation #2 was made using the following ingredients in theamounts indicated:

Ingredient Amount Glucosamine HCl 750.00 mg Dicalcium phosphate 269.90mg Ginger Root Extract 180.00 mg Microcrystalline Cellulose 56.00 mgBromelain 50.00 mg Green Tea Extract Powder 50.00 mg Stearic Acid 20.00mg Acacia powder 17.60 mg Sodium starch glycolate 15.00 mg SiliconDioxide 6.00 mg Calcium Stearate 0.50 mg

Tablet formulation #3 was made using the following ingredients in theamounts indicated:

Ingredient Amount Glucosamine Sulfate 510.00 mg Calcium Carbonate 269.90mg Ginger Root Extract 100.00 mg Microcrystalline Cellulose 56.00 mgBromelain 75.00 mg Green Tea Extract Powder 75.00 mg Stearic Acid 20.00mg Hydroxy Propyl Cellulose 17.60 mg Croscarmellose Sodium 15.00 mgSilicon Dioxide 6.00 mg Calcium Stearate 0.50 mg

The following procedure was performed-to make a tablet formulation #1,tablet formulation #2, and tablet formulation #3.

Weighing

All materials to be weighed were moved to a weighing area. Afterweighing, each ingredient was placed into a clean, poly lined containerthat was appropriately labeled.

Granulation

The solvent (water) and binder (hydroxypropylcellulose) were placed intoa clean, stainless steel liquid mixer until the binder was dissolved.Glucosamine was placed into a separate clean, dry, stainless steel mixerand dry mixed for four minutes. With the mixer running, thesolvent/binder solution was slowly added. The mixing continued until auniform agglomeration occurred. Additional solvent was added, if all thematerial did not become wet and agglomerated. Each resulting wetgranulation was placed on a clean, lined tray to a thickness of aboutone inch. Each granulation was dried in a drying room for about sixhours at 42° C. Each dried granulation was checked for moisture contentusing a moisture analyzer. The moisture content should be within 1percent of the moisture content of the materials prior to granulating.If additional drying was required, the material was returned to thedrying room. Each dried granulation was milled through a clean, dry,stainless steel mill (Model D Fitzmill). Each milled granulation wasplaced in clean, poly lined containers that were properly labeled.

Premix

Bromelain, calcium carbonate, ginger root extract, and silicon dioxidewere placed into a clean, dry, stainless steel V-blender. Large quantitymaterials were added first and last with small quantity materials beingadded in the middle. The mixture was mixed for ten minutes. Afterblending, the mixture was checked for lumping and uniformity. If eitherlumping or non-uniformity was noted, the material was screened andremixed. If the blend was uniform, the premix mixture was placed into aclean, poly lined container that was properly labeled.

Blending

The premix mixture and the milled granulation mixture were placed into aclean, dry, stainless steel V-blender. Green tea extract powder,magnesium stearate, stearic acid, microcrystalline cellulose, andcroscarmellose sodium were screened and then added. Large quantitymaterials were added first and last with small quantity materials beingadded in the middle. The mixture was mixed for ten minutes. Afterblending, the resulting mixture was screened and then blended for anadditional two minutes if lumping or non-uniformity was observed. Theresulting blended mixture was placed into a clean, poly lined containerproperly labeled for compressing.

Compressing

The resulting blended mixture was pressed into tablet using a cleantablet press (Manesty; Stoke Company). Once pressed to thespecification, each tablet was discharged through a tablet deduster andcollected in a clean, poly lined corrugated container.

Coating

The tablets were placed onto a clean, dry, side-vented, stainless steelcoating pan. The coating system settings used in the Vector High Coater170 were as follows:

Mist checkers set to read 100/Atomization air, and 120 pattern air,total air 220

Nozzle air set to 65 to 70 psi

Fluid gear pump set to 90 mL/minute delivery rate/gun

Spray guns positioned 9 to 10 inches from the rotating tablet bed

Heater intake set to 90° C.

Control airflow set to obtain 40° C. exhaust air temperature

Pan rotation speed set to 4 rpm for Model 150 pan and 2.5 rpm for Model170 pan

The tablet bed was gently heated to 30 to 35° C. When a tablet bedtemperature of 30 to 35° C. was reached, the coating pan wascontinuously rotated and the spray coating initiated. The coatingcontinued to obtain a 1.5 percent weight gain over the weight of anun-coated tablet. Upon completion of spray coating, pan rotationcontinued and about 300 to 400 gm of fine powder Carnauba Wax 13-300 wasapplied. The pan rotation continued until a high gloss was obtained. Thetablets were dried in the jogging pan with the air on for about ten 10minutes to remove moisture. The tablets were then collected into aclean, lined, corrugated container.

Example 2 Dietary Supplements Formulated as a Powder

Powder formulation #1 was made using the following ingredients in theamounts indicated. These amounts can equal the amount needed in a dailyserving.

Ingredient Amount Glucosamine sulfate 1525.00 mg Calcium Citrate 100.00mg Ginger Root Extract 275.00 mg Fructooligosaccharides 1500.00 mgMaltodextrin 2500.00 mg Bromelain 125.00 mg Green Tea Extract 500.00 mgFlavoring agent 5.00 mg Ascorbic Acid 75.00 mg Tartaric acid 15.00 mgSilicon Dioxide 4.00 mg Fructose 1500.00 mg

Example 3 Dietary Supplements Formulated as a Capsule

Capsule formulation #1 was made using the following ingredients in theamounts indicated:

Ingredient Amount Glucosamine HCl 510.00 mg Calcium Citrate 100.00 mgGinger Root Extract 75.00 mg Rice flour 56.00 mg Enzyme blend* 70.00 mgGreen Tea Extract 75.00 mg Magnesium Stearate 10.00 mg Hydroxy PropylCellulose 50.00 mg Silicon Dioxide 6.00 mg *Enzyme blend contains fungalprotease, acid protease, and papain

Example 4 Reducing Pain, Inflammation, Stiffness, and Discomfort usingDietary Supplements

Two humans suffering from joint problems started taking three tabletsdaily. The tablets were tablet formulation #1 tablets described inExample 1. The tablets were taken in the mid morning with or withoutbreakfast. After a few days to a week, each person reported noticeableimprovement. The improvements included a reduction in pain and stiffnessin their joints.

OTHER EMBODIMENTS

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are within the scope of thefollowing claims.

1. A method for reducing pain, inflammation, stiffness, or discomfort ina mammal, said method comprising administering a dietary supplement tosaid mammal in an amount effective to reduce said pain, inflammation,stiffness, or discomfort, wherein said dietary supplement comprises anaminosaccharide, a ginger component, and an enzyme, wherein saidaminosaceharide is granulated glucosamine or a granulated glucosaminesalt selected from the group consisting of glucosamine hydrochloride,glucosamine sulfate, glucosamine phosphate, glucosamine lactate, andglucosamine dodecanoate; wherein said dietary supplement is in the formof a tablet; and wherein about 40% to about 55% of said tablet by weightis said aminosaccharide.
 2. The method of claim 1, wherein said mammalreceives a daily dose of said glucosamine, said daily dose being between2 mg/kg and 20 mg/kg of body weight of said glucosamine.
 3. The methodof claim 1, wherein said ginger component is ginger oil.
 4. The methodof claim 3, wherein said mammal receives a daily dose of said gingeroil, said daily dose being between 25 mg/kg and 50 mg/kg of body weightof said ginger oil.
 5. The method of claim 1, wherein said gingercomponent is gingerroot or gingerroot extract.
 6. The method of claim 1,wherein about 5% to about 15% of said tablet by weight is said gingercomponent.
 7. The method of claim 1, wherein said enzyme is selectedfrom the group consisting of bromelain, papain, frugal proteases, acidstable proteases, neutral stable proteases, and alkaline stableproteases.
 8. The method of claim 1, wherein about 1% to about 10% ofsaid tablet by weight is said enzyme.
 9. The method of claim 1, whereinsaid dietary supplement comprises at least two different enzymes. 10.The method of claim 1, wherein said dietary supplement comprises a greentea extract.
 11. The method of claim 10, wherein about 1% to about 10%of said tablet by weight is said green tea extract.
 12. The method ofclaim 1, wherein daily administration of said dietary supplement to amammal for at least two weeks reduces pain, stiffness, or inflammationin said mammal.
 13. The method of claim 1, wherein said tablet ranges inweight from about 1000 mg to about 1500 mg.